Healthy Aging in Neighborhoods of Diversity Across the Life Span (HANDLS) Wave 3
| Tracking Information | |||||
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| First Received Date ICMJE | March 24, 2011 | ||||
| Last Updated Date | May 15, 2013 | ||||
| Start Date ICMJE | June 2009 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01323322 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Healthy Aging in Neighborhoods of Diversity Across the Life Span (HANDLS) Wave 3 | ||||
| Official Title ICMJE | Healthy Aging in Neighborhoods of Diversity Across the Life Span (HANDLS) Wave 3 | ||||
| Brief Summary | The Healthy Aging in Neighborhoods of Diversity across the Life Span study (HANDLS) is a multidisciplinary, community-based, prospective longitudinal epidemiologic study examining the influences of race and socioeconomic status (SES) on the development of age-related health disparities among socioeconomically diverse African Americans and whites in Baltimore. This study investigates whether health disparities develop or persist due to differences in SES, differences in race, or their interaction. This study is unique because it will assess over a 20-year period physical parameters as well as evaluate genetic, biologic, demographic, and psychosocial parameters of African American and white participants in higher and lower SES. It also employs novel research tools, mobile medical research vehicles, in hopes of improving participation rates and retention among non-traditional research participants. The domains of the HANDLS study include: nutrition, cognition, biologic biomarkers, body composition and bone quality, physical function and performance, sociodemographics, psychosocial, neighborhood environment and cardiovascular disease. Utilizing data from these study domains will facilitate understand the driving factors behind persistent black-white health disparities in overall longevity, cardiovascular disease, and cognitive decline. HANDLS Wave 1, the initial recruitment and examination phase that began in August 2004, is complete. The current protocol outlines the revisit waves of this study HANDLS Wave, 2 entitled, The Association of Personality and Socioeconomic status with Health Status - An Interim Follow-up Study, which began in June 2006 under a separate protocol is designed as a telephone interview to occur approximately 18 months after the first visit to the mobile Medical Research Vehicles (MRVs). Wave 2 provides interim contact with study participants, and important interim information regarding their health. The next visit HANDLS Wave 3 will consist of the second visit to the mobile Medical Research Vehicles (MRVs) for a health examination to occur at least 3 years after the first, a telephone interview to include the dietary interview and questionnaires, and for a random sample of those who participate in the revisit a direct measurement of renal function and a brain scan study using M RI to examine the structure of the brain. |
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| Detailed Description | The Healthy Aging in Neighborhoods of Diversity across the Life Span study (HANDLS) is a multidisciplinary, community-based, prospective longitudinal epidemiologic study examining the influences of race and socioeconomic status (SES) on the development of age-related health disparities among socioeconomically diverse African Americans and whites in Baltimore. This study investigates whether health disparities develop or persist due to differences in SES, differences in race, or their interaction. This study is unique because it will assess over a 20-year period physical parameters as well as evaluate genetic, biologic, demographic, and psychosocial parameters of African American and white participants in higher and lower SES. It also employs novel research tools, mobile medical research vehicles, in hopes of improving participation rates and retention among non-traditional research participants. The domains of the HANDLS study include: nutrition, cognition, biologic biomarkers, body composition and bone quality, physical function and performance, sociodemographics, psychosocial, neighborhood environment and cardiovascular disease. Utilizing data from these study domains will facilitate understand the driving factors behind persistent black-white health disparities in overall longevity, cardiovascular disease, and cognitive decline. HANDLS Wave 1, the initial recruitment and examination phase that began in August 2004, is complete. The current protocol outlines the revisit waves of this study HANDLS Wave, 2 entitled, The Association of Personality and Socioeconomic status with Health Status - An Interim Follow-up Study, which began in June 2006 under a separate protocol is designed as a telephone interview to occur approximately 18 months after the first visit to the mobile Medical Research Vehicles (MRVs). Wave 2 provides interim contact with study participants, and important interim information regarding their health. The next visit HANDLS Wave 3 will consist of the second visit to the mobile Medical Research Vehicles (MRVs) for a health examination to occur at least 3 years after the first, a telephone interview to include the dietary interview and questionnaires, and for a random sample of those who participate in the revisit a direct measurement of renal function and a brain scan study using M RI to examine the structure of the brain. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Time Perspective: Prospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Not Provided | ||||
| Study Population | Not Provided | ||||
| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 4000 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE |
Verified HANDLS participants Able to give informed consent Must have valid picture identification EXCLUSION CRITERIA: Pregnancy Within 6 months of active treatment of Cancer (Chemotherapy, biologic, radiation) |
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| Gender | Both | ||||
| Ages | 34 Years to 69 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01323322 | ||||
| Other Study ID Numbers ICMJE | 999909248, 09-AG-N248 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | National Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) ) | ||||
| Study Sponsor ICMJE | National Institute on Aging (NIA) | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | National Institutes of Health Clinical Center (CC) | ||||
| Verification Date | October 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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